Pharmacovigilance Reporting Specialist
Location: Chennai / Trivandrum / Bangalore, India (Office with Flex)
Job Requisition ID: JR144110
Employment Type: Full-Time
Category: Pharmacovigilance / Drug Safety
Job Overview
A leading global clinical research organization is hiring a Pharmacovigilance Reporting Specialist to support global drug safety and regulatory compliance operations across India. This hybrid (Office with Flex) role is ideal for experienced pharmacovigilance professionals with strong expertise in safety submissions, regulatory reporting, and signal data analysis within clinical research or pharmaceutical environments.
The selected candidate will play a key role in ensuring accurate, timely, and compliant pharmacovigilance reporting in alignment with global regulatory standards and internal quality systems.
Key Responsibilities
Safety Reporting & Regulatory Submissions
Lead safety submission activities for complex global clinical projects.
Prepare, review, and submit pharmacovigilance reports including Periodic Safety Update Reports (PSURs), Individual Case Safety Reports (ICSRs), and other aggregate safety reports.
Ensure compliance with global regulatory authorities including FDA, EMA, MHRA, and other applicable agencies.
Project & Process Management
Oversee safety submission–related projects to ensure timelines, financial scope, and quality standards are achieved.
Support end-to-end pharmacovigilance reporting workflows and cross-functional coordination.
Maintain inspection readiness and audit compliance for safety documentation.
Data Analysis & Signal Assessment
Conduct safety data analysis to identify trends and assess benefit-risk profiles of pharmaceutical products.
Support signal detection activities and regulatory safety assessments.
Utilize pharmacovigilance databases and reporting tools to ensure high data integrity.
Cross-Functional Collaboration & Training
Collaborate with clinical operations, regulatory affairs, medical teams, and sponsors to ensure timely adverse event reporting.
Provide training and mentorship to team members on pharmacovigilance reporting processes and regulatory requirements.
Stay updated with evolving global pharmacovigilance regulations and industry best practices.
Required Qualifications & Experience
Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline. Advanced degree preferred.
Minimum 6+ years of experience in pharmacovigilance reporting and safety submissions within a pharmaceutical, biotechnology, or clinical research organization.
At least 1 year of project management experience, including oversight of timelines, financial scope, and deliverables.
Strong expertise in PSURs, ICSRs, and aggregate safety reporting.
Proficiency in pharmacovigilance databases and safety reporting systems.
Advanced analytical skills with strong attention to detail and regulatory compliance.
Excellent written and verbal communication skills.
Demonstrated ability to work in cross-functional and global team environments.
Preferred Competencies
Experience working on global clinical trials and post-marketing surveillance programs.
Familiarity with global pharmacovigilance regulations and GVP guidelines.
Strong quality mindset with a commitment to compliance and patient safety.
Why Apply
Opportunity to work with a globally recognized healthcare intelligence and clinical research organization.
Exposure to international regulatory frameworks and global safety reporting processes.
Collaborative and inclusive work culture focused on innovation and excellence.
Competitive compensation and comprehensive employee benefits aligned with industry standards.
Career development opportunities within global drug safety and pharmacovigilance operations.
Equal Opportunity Statement
The organization is committed to fostering an inclusive and accessible workplace. All qualified applicants will receive equal consideration for employment without discrimination based on race, religion, gender, disability, veteran status, or any other protected characteristic. Reasonable accommodations are available throughout the recruitment process.
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